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FDA CRL setback: Grace Therapeutics’ GTx-104 for aneurysmal subarachnoid hemorrhage
Grace Therapeutics said the FDA issued a complete response letter for its GTx-104 NDA, delaying the company’s attempt to update the standard of care for aneurysmal subarachnoid hemorrhage. Grace...
Biopharma dealmaking: UCB’s up-to-$1.15B acquisition of Neurona Therapeutics
UCB announced an agreement to buy Neurona Therapeutics in a deal valued at up to $1.15 billion, including $650 million upfront and milestone payments. Neurona’s lead asset, NRTX-1001, is focused...
New European imaging and analytics tools (product launches) for oncology and translational research
New diagnostics and spatial analytics launches rolled out for research and translational programs. Qlucore introduced Qlucore Insights for bladder cancer, a research-use-only...
Venture capital: Kurma Partners closes €215M fund
Kurma Partners closed its fourth and largest venture fund, raising €215 million, targeting investments in disruptive therapeutic companies. Kurma said previous exits included Corlieve...
U.S. corporate expansion for single-cell tumor ecosystem profiling: One Biosciences picks Albany
One Biosciences will establish its first U.S. location in Albany, New York, building and staffing a high-complexity lab and computational analytics operation. Institut Curie-backed, the company...
FDA-CMS coverage alignment for breakthrough medical devices (RAPID pathway)
The FDA and CMS announced a new regulatory pathway—Regulatory Alignment for Predictable and Immediate Device, or RAPID—to speed Medicare national coverage decisions for breakthrough medical...
Cell therapy platform scaling: bioreactor method for weekly macrophage production
Researchers at Hannover Medical School (MHH) published a method to produce human immune cells in medium-sized bioreactors, converting induced pluripotent stem cells into immune-cell factories. The...
Drug development pipeline: ATR inhibition strategy advances with alnodesertib
Artios is advancing alnodesertib, an oral ATR inhibitor with an N-linked sulfoximine intended to improve selectivity within the PIKK family. Early combination results with irinotecan reported...
FDA accelerates psychedelics reviews via priority vouchers
The FDA moved to speed reviews for three psychedelic drug programs, issuing national priority review vouchers tied to Compass Pathways’ psilocybin treatment-resistant depression program, Usona...
Regeneron wins first FDA approval for gene therapy under national priority vouchers
Regeneron’s hearing loss gene therapy Otarmeni (lunsotogene parvec) won FDA approval for a rare inherited type of hearing loss caused by otoferlin variants, becoming the first gene therapy cleared...
EU regulators back Sanofi MS drug after US safety rejection
Sanofi’s tolebrutinib program for non-relapsing secondary progressive multiple sclerosis cleared another hurdle in Europe after the FDA issued a complete response letter in the U.S. Earlier FDA...
FDA–CMS move to speed Medicare coverage decisions for breakthrough devices
The FDA and CMS launched the RAPID coverage pathway, a new mechanism intended to reduce the lag between FDA authorization of selected breakthrough medical devices and Medicare national coverage...
FDA transparency: citizen petition challenges publication of CRLs
An unnamed biopharma sponsor filed a citizen petition asking the FDA to change its approach to publicly releasing complete response letters (CRLs), arguing the disclosure process is unlawful and...
Grace Therapeutics CRL stalls aneurysmal subarachnoid hemorrhage NDA
Grace Therapeutics said the U.S. FDA issued a complete response letter for its GTx-104 NDA in aneurysmal subarachnoid hemorrhage, delaying the company’s bid to update the standard of care. The...
UCB expands neuro pipeline via Neurona Therapeutics takeover
UCB agreed to acquire Neurona Therapeutics in a deal sized at up to about $1.15 billion, aiming to broaden its neurology pipeline around epilepsy. Neurona’s lead program, NRTX-1001, is being...
Tumor profiling and diagnostics: One Biosciences chooses Albany for U.S. expansion
One Biosciences, an Institut Curie-backed startup building AI-driven single-cell profiling tools for tumor ecosystems, selected Albany, New York as its first U.S. location. The company plans a...
Biotech venture capital: Kurma Partners closes €215M fund
Kurma Partners closed its fourth and largest venture fund at €215 million, targeting investments in companies pursuing disruptive therapeutic solutions. The fund builds on Kurma’s track record,...
Ray Therapeutics secures Series B to advance optogenetic retinal gene therapy
Ray Therapeutics raised $125 million in a Series B financing to advance retinal gene therapy programs, including clinical development and commercial readiness for its lead optogenetic asset...
Regulatory approvals and label decisions
The FDA cleared Regeneron’s gene therapy Otarmeni (lunsotogene parvec) for a rare inherited form of hearing loss caused by otoferlin variants, marking the first FDA approval for a gene therapy...
EU regulatory support for Sanofi tolebrutinib after FDA rejection
Sanofi’s tolebrutinib is receiving a regulatory lift in Europe after the FDA rejected the drug due to safety concerns, according to reports. The Committee for Medicinal Products for Human Use...